Date: 12 Aug 1998 23:01:33
From: aidsnews@igc.org
Subject: AIDS Treatment News #300
AIDS TREATMENT NEWS Issue #300, August 7, 1998
phone 800-TREAT-1-2, or 415-255-0588
CONTENTS:
T-20: New Trial Enrolling, 9 U.S. Cities
New Vaccine+HAART Treatment Trial Enrolling at NIH
Ritonavir Capsule Manufacturing Problems Will Require Switch
to Liquid Formulation
Geneva Medical Report Now on Web
Viral Load: Roche Applies for Marketing Approval for
UltraSensitive Test
IHV 1998 Annual Meeting (Gallo Lab Meeting) August 23-29 in
Baltimore
Geneva Update Town Hall Meeting, August 17, Redwood City,
California
San Francisco: Employment-Issues Training for Service
Providers, August 19
AIDS Meals and Nutrition Conference, September 10-13, San
Francisco
Rural AIDS Conference, Sept. 10-12, Albuquerque
Hepatitis C Conference, August 23-25 in Oakland
Medical Marijuana: Healing Alternatives Begins Distribution
Nutritional Supplements: Call for Information
***** T-20: New Trial Enrolling, 9 U.S. Cities
by John S. James
On July 30 Trimeris, Inc. announced a trial of T-20, an
experimental drug based on an important new approach to
antiretroviral treatment. This study, called TRI-003, will
enroll up to 78 volunteers at 11 sites in 9 U.S. cities. It
will be relatively easy to qualify for entry, since
volunteers can be on any stable antiretroviral regimen (or on
none at all)--and there are no exclusions for previous use of
any antiretrovirals. A viral load of at least 5,000 is
required (so that antiretroviral activity of the drug can be
measured), and there are some other entry criteria.
T-20 is a synthetic 36-amino-acid peptide which is identical
to part of the HIV virion itself; it remains outside human
cells and blocks a specific step in the process by which HIV
enters new cells (see AIDS TREATMENT NEWS issue #293, April
17, 1998; also #279, September 19, 1997). In a previous human
trial T-20 caused a very rapid drop in viral load, with no
known adverse effects from the drug. But that early test was
limited, because the largest and most effective dose was
tested in only four patients; also, T-20 was injected twice a
day, an inefficient means of delivery. The new trial will
test continuous administration of T-20 by subcutaneous
infusion, using a small, pager-size pump, developed by
MiniMed Inc., which is currently in widespread use for
delivering insulin to diabetics.
The new trial will run for 28 days; its purpose is to learn
more about the antiretroviral activity, safety, and plasma
pharmacokinetics of T-20. Longer tests will begin after more
has been learned about dosage, and after long-term animal
safety data has been obtained from ongoing tests. According
to Trimeris, volunteers who achieve sustained HIV suppression
on TRI-003 will be eligible for another T-20 study which will
explore long-term use.
TRI-003 replaces TRI-002, a smaller trial announced June 25.
TRI-002 would have required indinavir failure as an entry
condition, and also required three particular antiretrovirals
to be used in combination with T-20.
Comment
Trimeris changed its study plans after discussions with the
trial investigators, community advocates including this
writer, and the FDA. We believe that the specific drug
requirements of earlier designs would have created serious
recruiting, adherence, and other problems, for no purpose.
Since T-20 has a completely different mechanism of action
than any other antiretroviral in human use, all exclusions
for prior or concurrent treatments are unnecessary; what the
trial does need is treatment stability, so that the effects
of T-20 on viral load can be determined. The TRI-003 design
got it right.
One theoretical concern about volunteering for this study is
that since so little is now known about how to use T-20, it
is possible that doses tested will be too low to fully
suppress HIV, which could lead to the development of viral
resistance and prevent volunteers from benefiting from T-20
later. Although this risk appears to be small, resistant
virus has been created in laboratory cultures. Volunteers and
their physicians will have access to viral load results
during TRI-003.
Also, the earlier trial found a very rapid drop of viral load
with an adequate T-20 dose--perhaps even faster with T-20
alone than with the combination antiretrovirals currently in
use. This rapid decline of virus, plus the avoidance of most
of the adherence and absorption variability of oral drugs,
may reduce the risk of viral resistance. And even if T-20
resistance did occur, there would almost certainly be no
cross resistance with any other antiretroviral in human use.
For More Information
For information about volunteering for this trial, call the
study coordinator at a site near you (the "contact" listed
below). The trial locations are listed alphabetically by city
(New York and San Francisco each have two sites). Note that
each site cannot begin the trial until it has been approved
by the local IRB (institutional review board). But volunteers
can call now for more information, and to begin the process
or at least get on a waiting list.
Birmingham: University of Alabama. Principal investigator:
Michael Kilby, M.D. Contact: Leslie Alldredge, 205-975-9128.
Boston: Community Research Initiative of New England.
Principal investigator: Cal Cohen, M.D. Contact: Ruth Cooper,
617-566-4004 ext. 49.
Chapel Hill: University of North Carolina. Principal
investigator: Joseph J. Eron, M.D. Contact: Limh Ngo, 919-
966-6712.
Chicago: Northwestern University. Principal investigator:
Robert Murphy, M.D. Contact: Joyce Drury, R.N., 312-908-7873.
Houston: University of Texas. Principal investigator: Roberto
Arduino, M.D. Contact: Hilda Cuervo, 713-500-6751.
Los Angeles: UCLA. Principal investigator: Margrit Carlson,
M.D. Contact: Christine MacNaughton, 310-206-6414.
Maitland, Florida: Central Florida Research Initiative.
Principal investigator: C. Jeffrey Goodgame, M.D. Contact:
Bill Emery, R.N. C.C.R.C., 407-647-3960.
New York City: Bentley-Salick Medical Practice. Principal
investigator: Ramon Torres, M.D. Contact: Mary Catherine
George, 212-414-4624.
New York City: NYU Medical Center. Principal investigator:
Fred Valentine, M.D. Contact: Karen Cavanaugh, 212-263-8707.
San Francisco: Quest Clinical Research. Principal
investigator: Jacob Lalezari, M.D. Contact: Dr. Lalezari,
415-353-0800.
San Francisco: San Francisco General Hospital. Principal
investigator: Paul Volberding, M.D. Contact: Doug Raggett,
415-476-9296 ext. 312.
***** New Vaccine+HAART Treatment Trial Enrolling at NIH
by John S. James
A small trial at the U.S. National Institutes of Health (NIH)
will test a new kind of HIV vaccine, plus standard
antiretroviral therapy, to try to bring back HIV-specific
immune responses in volunteers with relatively early HIV
disease.
This trial is open to persons who currently have a CD4 count
of over 500, and who either are on antiretroviral treatment
already, or are willing to begin treatment. All study
medications will be paid for while the patient is in the
trial, which will last up to 18 months. In addition to the
antiretroviral treatment, there will be six injections of the
vaccine during a period of one year. NIH will pay for
transportation (except for the first trip), so volunteers do
not need to live in the Washington D.C. area.
Volunteers must never have had a CD4 count under 300, unless
the low count occurred during acute HIV infection.
The vaccine being tested consists of two HIV peptides of the
viral envelope, including the V3 loop. This is the first
trial in which these peptides together will be given to
humans. Each has been tested separately in a few people,
however (without the antiretroviral therapy), and no adverse
effects have been seen.
Intensive immunologic studies will be performed to see
whether HIV-specific responses--especially T-helper,
cytotoxic T lymphocyte (CTL), and neutralizing antibody
responses--can be restored by this vaccination while the
virus is being suppressed by the drugs. Such effects on HIV-
specific immunity have already been found in animal tests,
and some have been seen in the early human tests with the
peptides, even without the antiretroviral treatment.
Comment
Interest is growing rapidly in finding ways to restore HIV-
specific immune responses, which are usually lost very early
in the infection. A similar study, but using a different
vaccine, reported strikingly successful results at the recent
12th World AIDS Conference in Geneva (abstract #31227, late
breaker session #LB 9; see report in AIDS TREATMENT NEWS
#298, July 10, 1998).
These HIV-specific responses are maintained naturally by
long-term nonprogressors, but are lost by the great majority
of patients, who do progress to HIV disease. There is no data
yet on whether restoring these responses by treatment is
clinically beneficial.
For More Information
For more information about volunteering for this study,
contact either Tino Merced-Galindez, R.N. (800-772-5464 ext.
562, or 301-496-8959, or merced@box-m.nih.gov), or Richard
Little, M.D. (800-772-5464 ext. 657, or
rlittle@helix.nih.gov), at the HIV and AIDS Malignancy
Branch, National Cancer Institute.
***** Ritonavir Capsule Manufacturing Problems Will Require
Switch to Liquid Formulation
by John S. James
On June 27 Abbott held a conference call to inform the AIDS
community that a manufacturing problem has halted production
of ritonavir (Norvir(TM)) capsules. The supply on hand will
start to run out in August (some pharmacies may still have
capsules later), and then patients will need to switch to the
liquid formulation of ritonavir, which remains available (or
switch to a different treatment regimen). No one knows when
the manufacturing of the capsules can be resumed.
The problem is that the ritonavir in the capsules started to
crystallize. While the crystal is still the same chemical, it
does not dissolve as fast, and therefore would be absorbed
differently. Abbott discovered the problem during routine
quality-assurance tests.
According to Abbott, all the capsules which have been shipped
to pharmacies and distributors are OK.
Switching to Ritonavir (Norvir) Liquid
The liquid formulation (sometimes called "Norvir oral
solution") provides the same drug as the capsules. Therefore
the switch should not require a doctor's visit, although the
pharmacist may have to call the doctor to get permission to
substitute the different formulation when the prescription
for the capsules needs to be refilled and the pharmacy has no
more capsules in stock. It is likely that most people will
change to the liquid formulation, since switching to a
different protease inhibitor, or other HIV treatment,
involves more difficult medical decisions.
The price of the drug should be about the same for either
formulation.
The main disadvantage of the liquid is its very bad taste.
The package insert suggests, "Patients may improve the taste
of Norvir oral solution by mixing with chocolate milk,
Ensure(R), or Advera(R) within one hour of dosing."
Until now the oral solution has been used mostly for
children, so that they could be given the correct dose for
their body size. Since the bad taste is a serious obstacle in
getting children to take the drug, pediatricians have had the
most experience in masking the taste. One suggestion is to
take a spoonful of chocolate syrup before the dose, and then
again after the dose. A popsicle may help reduce the bad
taste by chilling the taste buds. Another suggestion is to
use a straw to deliver the drug to the back of the throat.
(We thank Search for a Cure for this information, which it
learned from pediatricians who use the liquid formulation.)
Note that the oral solution (unlike the capsules) should
*not* be refrigerated by the patient. According to the
package insert:
"Recommended storage: Store Norvir oral solution at room
temperature 68 degrees F to 77 degrees F (20 degrees C to 25
degrees C). Do not refrigerate. Shake well before each use.
Use within 30 days from dispensing.
"Product should be stored and dispensed in the original
container. Avoid exposure to excessive heat. Keep cap tightly
closed."
What if the temperature in one's home goes above 77 degrees?
A preliminary recommendation (which Search for a Cure heard
from Abbott) is that if the temperature gets hotter than 86
degrees, put the drug in the refrigerator. But if any
official recommendation is issued in the future, it is the
one that should be followed.
The Norvir Web site (http://www.norvir.com) has measuring
instructions:
"Each Norvir capsule contains 100 mg of active drug, and each
mL of Norvir liquid contains 80 mg of active drug. For your
convenience, Norvir liquid comes with a dosing cup that
provides markings indicating the amount of liquid to be taken
for the two most common doses. It is important to measure the
correct dose of Norvir; therefore, the dosing cup has been
specially designed to provide the right dose of Norvir
liquid. This cup should be used to measure a dose. Please be
advised that when measuring a dose, the cup should be placed
on a flat surface at eye level, and the cup filled with
Norvir liquid to the line showing the appropriate dose. You
should wash the dosing cup with soap and warm water as soon
as possible. The dosing cup is not dishwasher safe.
"The following conversion equation may be helpful:
"6 Norvir capsules (100 mg each) = 7.5 mL of Norvir liquid (1
1/2 teaspoons)
"4 Norvir capsules (100 mg each) = 5 mL of Norvir liquid (1
teaspoon)."
For More Information
For more information about the ritonavir capsule shortage and
the oral solution, call your physician. Or check Abbott's Web
site at http://www.norvir.com, or call the Norvir information
hotline, 800-637-2400, 7:00 a.m. to 7:00 p.m. Central time.
***** Geneva Medical Report Now on Web
by John S. James
An excellent two-hour summary of major practical themes from
the 12th World AIDS Conference, intended primarily for HIV
care providers, is now available in both text and audio on
the Web. This program, two panel discussions sponsored by the
Johns Hopkins University AIDS Service, the University of
California San Francisco AIDS Program at San Francisco
General Hospital, and the U.S. Health Resources and Services
Administration (HRSA), had a projected audience of 100,000
through an interactive satellite broadcast, a simultaneous
interactive netcast, and the transcript and audio which is
the subject of this announcement. Unlike most medical
programs today, it was not financed by pharmaceutical
companies.
The discussions were led by John G. Bartlett, M.D., from
Johns Hopkins, and Paul Volberding, M.D., from San Francisco
General Hospital. Since this conversation occurred a month
after the conference, the eight panelists, all physicians,
had had time to reflect on which information was most
important for medical care today and in the near future.
While intended mainly for medical professionals, this
material will be useful for patients as well.
A disadvantage of the archived program is that the transcript
was made quickly, without time for the presenters to correct
it; as of this writing there were minor ambiguities or
possibilities for misinterpretation in the written version.
The audio feed, which is good quality, avoids most of these
problems, but requires fairly modern computer equipment and
software. Individuals or organizations might want to tape the
audio to make it available to persons who do not have the
computer equipment required to receive it directly. In any
case, it may be useful to listen to the audio while following
the written text as well, since learning is most effective
when material is both seen and heard.
Topics discussed include new antiretrovirals (especially
efavirenz), protease inhibitors and how to use them,
hydroxyurea, when to start antiretroviral treatment, HIV
treatment during pregnancy, more sensitive viral load tests,
viral resistance testing, post-exposure prevention, the
possibility of less aggressive antiretroviral approaches,
adherence issues, twice daily and even once-daily
antiretroviral dosing regimens, body-shape changes and
metabolic disorders, salvage therapy, cost-effectiveness of
antiretroviral treatment, underserved populations, access to
care, prevention of mother-infant transmission, and the need
for experienced physicians in quality HIV care.
Both the written transcript and the audio program are
available at http://hopkins-aids.edu/geneva/info.html.
***** Viral Load: Roche Applies for Marketing Approval for
UltraSensitive Test
On June 26 Roche Molecular Systems, Inc. applied to the FDA
for permission to market a more sensitive viral load test.
The test that is commercially available today can reliably
quantify viral load to as low as 400 copies per milliliter of
plasma; the new method extends this limit of quantification
to 50 copies. The new test, called the Amplicor HIV-1
Monitor(TM) UltraSensitive Method, is actually an optional
specimen processing procedure used with the currently
available test (the Amplicor HIV-1 Monitor).
At the recent Geneva conference, a widespread consensus
emerged that physicians will want a test which measures below
the current 400-copy limit; one reason is that patients who
get to very low levels are likely to keep the virus
suppressed for longer than those whose viral load is close to
400. However, in many cases it will be difficult to advise
patients who have test results between 50 and 400, since
there can be significant costs or drawbacks to changing
antiretrovirals.
Many physicians are already using the more sensitive viral
load tests; the Roche UltraSensitive method has been
available to researchers in the U.S. since February 1997.
Commercial approval will reduce problems of access to a test
which is now widely agreed to be useful.
***** IHV 1998 Annual Meeting (Gallo Lab Meeting) August 23-
29 in Baltimore
The annual meeting of the Institute of Human Virology--
traditionally known as the "Gallo lab meeting"--will take
place August 23-29 in Baltimore. Almost 200 oral
presentations will report advances in the basic sciences of
HIV infection, cancer, and hepatitis; most are highly
technical as they are intended for scientists working in
related fields. This year's meeting will be videotaped.
Program, registration, and other information is on the Web
site of the Institute of Human Virology, http://www.ihv.org.
Or you can call Jeff Meshulam, 410-706-8614.
***** Geneva Update Town Hall Meeting, August 17, Redwood
City, California
The AIDS Community Research Consortium and other HIV/AIDS
support organizations in San Mateo County will present a
report on the recent 12th World AIDS Conference, with a focus
on viral resistance, women and HIV, and cross-cultural
perspectives. It will be held Monday August 17 from 6:00 p.m.
to 8:30 p.m. at the Fair Oaks Community Center in Redwood
City, about 25 miles south of San Francisco.
Admission is free. To reserve a seat, call 650-364-6563 by
August 13.
***** San Francisco: Employment-Issues Training for Service
Providers, August 19
A free, one-day training on employment issues for San
Francisco AIDS service providers, vocational counselors, and
job placement specialists will be held Wednesday, August 19,
9 a.m. to 4 p.m. at the UCSF Laurel Heights Conference
Center, 3333 California St., San Francisco. Topics include
benefits issues, psychological aspects, job search training,
and vocational rehabilitation and training resources.
Persons interested are asked to register by August 12.
Contact AIDS Benefits Counselors, 415-558-9845, fax 415-703-
9942.
***** AIDS Meals and Nutrition Conference, Sept. 10-13, San
Francisco
The 5th annual AIDS Meals and Nutrition Providers Conference,
"Food Fight 98: Combating HIV Through Nutrition", will be
held September 10 through September 13 in San Francisco at
the Sir Francis Drake Hotel.
Keynote speakers are Drs. Paul Volberding and Molly Cooke.
Workshops include care for pregnant women, pediatric
assessments and interventions, dietary strategies to maximize
treatment efficacy, body composition and maintaining lean
muscle mass, and information about administration and
development of food-service programs.
The conference is sponsored by AIDS Nutrition Services
Alliance (ANSA), in Washington D.C. For conference and
registration information contact Cari Napoles, Conference
Coordinator, c/o Project Open Hand, 730 Polk Street, San
Francisco, CA 94109; phone 415-447-2471, fax 415-447-2493,
email cnap@openhand.org.
***** Rural AIDS Conference, September 10-12, Albuquerque
"The Southwestern Conference on Rural HIV/AIDS: Issues in
Prevention and Treatment," sponsored by the National Rural
Health Association (NHRA), will take place September 10
through September 12 at the Hyatt Regency Hotel, Albuquerque,
New Mexico. Scheduled speakers include: Sandra Thurman,
Director, Office of National AIDS Policy; and R. Scott Hitt,
M.D., Chair, Presidential Advisory Council on HIV/AIDS.
Registration deadline is August 28; some scholarships are
available.
For more information contact the NRHA: phone 816-756-3140,
fax 816-756-3144 email mail@nrharural.org, or see the Web
site at http://www.NRHArural.org/pagefile/eo.html.
***** Hepatitis C Conference, August 23-25 in Oakland
The HCV Global Foundation Second International HCV
Conference, "The Silent Epidemic of Hepatitis C," will take
place August 23-25 at Oakland Marriott City Center, Oakland,
California. This meeting is intended both for patients and
healthcare professionals.
For more information, call HCV Conference, c/o KREBS
Convention Management Services, 415-920-7000, fax 415-920-
7001.
***** Medical Marijuana: Healing Alternatives Begins
Distribution
by John S. James
Healing Alternatives Foundation, one of the oldest and
largest AIDS buyers' clubs, will begin medical marijuana
distribution on August 5.
John Salvati, Healing Alternatives general manager, described
this program to AIDS TREATMENT NEWS:
* To protect the physicians, they will not be asked to either
prescribe or recommend marijuana for their patients. The
physician cannot decide whether or not a patient can receive
the drug through this program; that decision will be made by
Healing Alternatives.
* Instead, physicians will be asked to acknowledge that they
are aware that their patient is using marijuana for medical
treatment, and that they will continue to provide treatment
with knowledge of that use.
* The treating physician will also be asked to confirm the
diagnosis of the serious or life-threatening condition for
which the patient is seeking access to the drug. Healing
Alternatives will only accept conditions for which medical
marijuana is recognized.
* All batches will be tested for microbiological
contamination.
* Healing Alternatives, which is a non-profit community-based
organization, will return any profits to the community and
fully disclose where that money is going. If they are able to
obtain donated marijuana, they will distribute it without
charge.
The following intake procedure will be used:
* All intake will be at the Castro Street office during
regular hours. (No marijuana will be dispensed or stored at
this office, however.)
* The first step is the physician's letter. Healing
Alternatives is using a draft created by the San Francisco
Department of Public Health for physician use; however, to
protect the doctor, Healing Alternatives removed one
sentence, in which the physician "recommends" cannabis use
for the patient. This letter may be either on the form
provided by Healing Alternatives, or on the physician's
letterhead.
In either case the physician certifies that the patient is
under his or her care for the treatment of ___; that he or
she has discussed the medical benefits and risks of cannabis
use with the patient as a treatment for these medical
conditions; and that if the patient chooses to use cannabis
therapeutically, the physician will continue to monitor the
patient's medical condition and to provide advice on his or
her progress. The statement also notes that the letter is for
the use of the patient and Healing Alternatives Foundation
only (not other marijuana distribution programs), that the
physician may be contacted to verify the information in the
letter, and that the patient authorizes the physician to
discuss his or her medical condition and the contents of the
letter with the center for verification purposes only. The
statement is signed by the patient and physician, dated, and
expires after a time period specified by the physician.
When the form is returned, the patient can join Healing
Alternatives; the annual membership fee is $10 to $35 for
persons in the medical-marijuana program, which includes a
contribution to a legal defense fund. After an intake
process, it takes about a week for Healing Alternatives to
verify the paperwork.
Financial need can always be taken into account.
Healing Alternatives is located at 505 Castro Street (at 18th
Street), 2nd floor; phone 415-626-4053. It is open Tuesday
through Friday from 12 noon to 6 p.m., and on Saturday from
noon to 5. Healing Alternatives sells selected nutritional
supplements, provides referrals, and distributes AIDS/HIV
treatment information.
***** Nutritional Supplements: Call for Information
by John S. James
AIDS TREATMENT NEWS is planning more coverage of nutritional
supplements used or potentially useful for persons with HIV.
We would like to hear from readers about what has or has not
helped them. We also welcome any comments on some of the
ethical and credibility issues of reporting in this area.
* We are most interested in what you have learned from
personal experience (either your own, or of persons you
know). Are you convinced that any particular supplement or
program has helped you, or a friend or other associate--or
has failed to help--or has been harmful in some way?
Let us know what you used (including how much, and how long),
why you tried it, and why you think it did or did not work
for you. Email or call John S. James, aidsnews@aidsnews.org,
or 415-255-6259.
Some of the difficulties in reporting on nutritional
supplements are:
* U.S. culture draws a sharp line--probably too sharp--
between "foods" and "drugs." Not all cultures do; for
example, there are Chinese restaurants where you can order by
describing certain ailments to the cook, who will prepare a
meal accordingly. In the U.S. they have needed to keep a low
profile, making a potentially fascinating and useful area
difficult to find or study.
* The food/drug divide has hurt research on both sides.
Nutritional research has often been ignored or greatly
underfunded. On the drug side, great sums are spent on poorly
designed research shaped by regulatory and promotional
purposes--especially clinical trials that look only or
primarily for statistically significant differences between
averages, while ignoring mechanisms of action, how and why
patients differ from each other, and who should or should not
be using the drug. (And a major but seldom-noted element of
the cost of medical care is that only expensive potential
remedies are likely to be developed, since they can finance
careers--even when cheaper approaches may be safer and more
appropriate.)
* Because nutritional supplements have less research data
than drugs while at the same time being more accessible, the
community of users is often well ahead of the academic world
in understanding their use. The lack of data, and the
disagreements among experts, can make reporting difficult.
* Sometimes the leading expertise on nutritional supplements
is in the sports world, especially body building. HIV/AIDS
uses may be similar or may be different.
* The supplements industry has become a money machine, with
far less government scrutiny over promotional statements than
applies to the pharmaceutical industry. It is hard to
distinguish the credible from the hype.
Where hard news is lacking, we may only be able to outline
plausible possibilities, which people may try to see what
works for them.
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Treatment News does not recommend particular
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AIDS Treatment News
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